Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-02-11 @ 12:42 PM
Study NCT ID:
NCT04192435
Status:
RECRUITING
Last Update Posted:
2024-12-16
First Post:
2019-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Matched TxA and placebo vials'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'double-blind, placebo-controlled, randomised trial of TxA versus placebo'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-10', 'studyFirstSubmitDate': '2019-11-27', 'studyFirstSubmitQcDate': '2019-12-08', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Surgical Site Infection', 'timeFrame': 'from surgical incision to 30 days post surgical incision', 'description': 'defined by the US Centers for Disease Control (CDC)'}], 'secondaryOutcomes': [{'measure': 'Red cell transfusion', 'timeFrame': 'from surgical incision to hospital discharge (from index surgery) or 30 days.', 'description': 'Total units given'}, {'measure': 'Other healthcare-associated infections', 'timeFrame': 'from surgical incision to 30 days', 'description': 'sepsis, pneumonia, blood stream infection, UTI, etc; all using CDC-guided definitions'}, {'measure': 'C-reactive protein', 'timeFrame': 'Postoperative Day 3 (three days after surgical incision)', 'description': 'peak'}, {'measure': 'Days at home up to 30 days after surgery (DAH30).', 'timeFrame': 'From surgical incision to 30 days', 'description': 'Time that patient spends at home in the 30 days following surgery'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infection Wound', 'Gastrointestinal Complication', 'Anesthesia', 'Bleeding', 'Healthcare Associated Infection']}, 'referencesModule': {'references': [{'pmid': '31126915', 'type': 'BACKGROUND', 'citation': 'Draxler DF, Yep K, Hanafi G, Winton A, Daglas M, Ho H, Sashindranath M, Wutzlhofer LM, Forbes A, Goncalves I, Tran HA, Wallace S, Plebanski M, Myles PS, Medcalf RL. Tranexamic acid modulates the immune response and reduces postsurgical infection rates. Blood Adv. 2019 May 28;3(10):1598-1609. doi: 10.1182/bloodadvances.2019000092.'}, {'pmid': '31317130', 'type': 'BACKGROUND', 'citation': 'Bell M, Eriksson LI, Svensson T, Hallqvist L, Granath F, Reilly J, Myles PS. Days at Home after Surgery: An Integrated and Efficient Outcome Measure for Clinical Trials and Quality Assurance. EClinicalMedicine. 2019 Apr 27;11:18-26. doi: 10.1016/j.eclinm.2019.04.011. eCollection 2019 May-Jun.'}]}, 'descriptionModule': {'briefSummary': "This international, multicentre, pragmatic, double-blind, placebo-controlled, randomised trial of TxA versus placebo will enrol 3,300 patients throughout Australia and internationally. This is an effectiveness trial - some elements of the trial are deliberately left to the perioperative clinicians' discretion in order to reflect usual practice and maximise generalisability.", 'detailedDescription': 'Study Aims: To conduct a large, multicentre clinical trial of tranexamic acid (TxA), an antifibrinolytic drug routinely used to reduce bleeding in cardiac and some orthopaedic surgery, in 3,300 patients undergoing major gastrointestinal (GI) surgery. Our specific aims are to investigate whether TxA:\n\nAim 1: Reduces surgical site infection ("wound infection"), and other healthcare-associated infections (pneumonia and sepsis).\n\nAim 2: Reduces red cell transfusion in GI surgery. Aim 3: Reduces a pooled composite of any serious postoperative complications, and so increases "days alive and at home up to 30 days after surgery" (DAH30).\n\nAim 4: To evaluate the temporal effect of TxA on perioperative immune and inflammatory responses.\n\nStudy Hypothesis Prophylactic TxA administration in patients undergoing major GI surgery reduces the incidence of surgical site infection (SSI) after surgery when compared with placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Adult patients scheduled for elective or semi-elective (inpatient) open or lap-assisted GI surgery (oesophageal, gastric, hepatobiliary, colorectal) with one or more risk factors for complications:\n\n* Age ≥70 years\n* ASA physical status 3 or 4\n* Known or suspected history of: heart failure, diabetes, peripheral vascular disease, or chronic respiratory disease\n* Obesity (BMI ≥30 kg/m2)\n* Anaemia (preoperative haemoglobin \\<130 g/l in males and \\<120 g/l in females)\n* Renal impairment (se. creatinine ≥150mol/l)\n* Low albumin (\\<30 g/L)\n\nExclusion Criteria:\n\n* Poor spoken and or written language comprehension\n* Laparoscopic cholecystectomy and other minor (eg. closure of stoma) surgery\n* Pre-existing infection/sepsis\n* Known history of: spontaneous pulmonary embolism, arterial thrombosis familial thrombophilia (e.g. Lupus anticoagulant, protein C deficiency, factor V Leiden)'}, 'identificationModule': {'nctId': 'NCT04192435', 'acronym': 'TRIGS', 'briefTitle': 'Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bayside Health'}, 'officialTitle': 'Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery; The TRIGS Trial', 'orgStudyIdInfo': {'id': '087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tranexamic acid', 'description': 'At induction of anesthesia and prior to surgical incision a bolus of 0.15 ml/kg ( up to a maximum of 15 ml) , and then commence an infusion of 0.05 ml/kg/h until the end of surgery. The total maximal administered study drug volume will be 30 ml.', 'interventionNames': ['Drug: Tranexamic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'At induction of anesthesia and prior to surgical incision a bolus of 0.15 ml/kg ( up to a maximum of 15 ml) , and then commence an infusion of 0.05 ml/kg/h until the end of surgery. The total maximal administered study drug volume will be 30 ml.', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Tranexamic Acid', 'type': 'DRUG', 'description': '100mg/ml', 'armGroupLabels': ['Tranexamic acid']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Placebo will be 5ml vials calculated to equivalent to the 100mg/ml of active drug.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Sophie Wallace, MPH', 'role': 'CONTACT', 'email': 's.wallace@alfred.org.au', 'phone': '+61390762651', 'phoneExt': '62651'}, {'name': 'Paul S Myles, MB.BS, MPH, MD,FCARCSI,FANZC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'centralContacts': [{'name': 'Paul S Myles, MD, DSc', 'role': 'CONTACT', 'email': 'p.myles@alfred.org.au', 'phone': '+61390763176', 'phoneExt': '3176'}, {'name': 'Sophie KA Wallace, MPH, RN', 'role': 'CONTACT', 'email': 's.wallace@alfred.org.au', 'phone': '+61390763176', 'phoneExt': '62651'}], 'overallOfficials': [{'name': 'Paul S Myles, MD, DSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Alfred Hospital and Monash University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Before recruitment of final patient', 'ipdSharing': 'YES', 'description': 'This decision will be made on a individual case by case basis, with formal request and review by the PI and steering committee.', 'accessCriteria': 'Patient and illness eligibility'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayside Health', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'National Health and Medical Research Council, Australia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}